Assessment of Primary Oxygenation and Airflow Measurement for Endoscopic Laryngeal Surgery

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03222869

Enrollment

Registered

2017-07-19

Start date

2017-03-29

Completion date

2022-05-31

Last updated

2023-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngotracheal Stenosis

Brief summary

This research is being done to determine the resistance across stenosis in the airway.

Detailed description

There is significant utility in objectively measuring airflow as subjects, undergoing endoscopic laryngeal surgery, commonly have difficulties with airflow secondary to their stenosis. Easier and quicker quantification will tailor diagnosis and treatment. In order to obtain an objective measure of airflow in these participants, we will place a 20-gauge angiocatheter needle into the airway. The catheter will be in situ for a short duration during several spontaneous and non-spontaneous breaths. This will be achieved via the existing tracheostomy stoma or percutaneously via the cricothyroid membrane. This technique is commonly used to access the muscles of the larynx, however, the primary purpose will be to measure airflow in this setting.

Interventions

DIAGNOSTIC_TESTMeasure Airway Resistance Across Stenosis

Measure pressure and air flow Across Stenosis

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Patients 18 years or older that require outpatient endoscopic laryngeal airway surgery, in the operating room, at a tertiary academic center.

Exclusion criteria

* Pregnancy (status will be determined by a urine test as part of standard clinical care in the preoperative setting) * Patients that are not cleared for surgery by the preoperative evaluation * Patients with severe laryngotracheal stenosis * Patients who are morbidly obese (BMI \> 40) * Patients with lung disease (asthma, COPD)

Design outcomes

Primary

Measure	Time frame	Description
Pressure (cm H20)	Up to One Year	Using a pressure gauge to measure pressure at locations in the airway

Secondary

Measure	Time frame	Description
Flow Rate (L/min)	Up to One Year	using a flow sensor to measure low rate at locations in airway

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026